Trial · NCT01467427
Registered outcomes29
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 29
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of Inhibitory Antibodies Against Coagulation Factor IX (FIX) Defined as Titre Above or Equal to 0.6 Bethesda Units (BU) | From week 0 to week 52 | Inhibitors were analysed with either the Nijmegen modified factor IX Bethesda assay or a heat/cold Nijmegen modified factor IX Bethesda assay. Number of participants who developed inhibitory antibodies against factor IX are reported. |
| Primary | Incidence of Inhibitory Antibodies Against Coagulation Factor IX (FIX) Defined as Titre Above or Equal to 0.6 Bethesda Units (BU) | From week 52 to End of trial (EOT) (approximately week 544) | Inhibitors were analysed with either the Nijmegen modified factor IX Bethesda assay or a heat/cold Nijmegen modified factor IX Bethesda assay. Number of participants who developed inhibitory antibodies against factor IX are reported. |
| Secondary | Number of Bleeding Episodes During Prophylaxis | From week 0 to EOT (approximately week 544) | The number of bleeding episodes per participant during routine prophylaxis was assessed using the individual annualised bleeding rates (bleeding episodes per participant per year). |
| Secondary | Haemostatic Effect of N9-GP in Treatment of Bleeding Episodes by 4-point Categorical Scale for Haemostatic Response (Excellent, Good, Moderate and Poor) | From week 0 to EOT (approximately week 544) | Description of the haemostatic effect of nonacog beta pegol when used for treatment of bleeding episodes was measured and listed according to the four point scale for haemostatic response as below: 1. Excellent - abrupt pain relief and/or clear improvement in objective signs of bleeding within 8 hours after a single infusion. 2. Good - noticeable pain relief and/or improvement in signs of bleeding within 8 hours after a single injection. 3. Moderate - probable or slight beneficial effect within the first 8 hours after the first injection but requiring more than one infusion within 8 hours. 4. Poor - no improvement, or worsening of symptoms within 8 hours after two injections. A success rate was calculated based on counting good or excellent as successes and poor and moderate as failures. |
| Secondary | Incremental Recovery at 30 Minutes (IR30min) | Week 0 (30 minutes after first exposure) | The incremental recovery was calculated by dividing the baseline-subtracted factor IX activity Units per milliliter (U/mL) measured in plasma 30 min after dosing by the dose injected at time 0 expressed as units per kilogram (U/kg) body weight. |
| Secondary | Trough Level (Single-dose ) | Week 0 (one week after first exposure) | The mean pre-dose factor IX levels was measured with the one-stage clotting assay during the trial. Geometric mean of the lowest activity of factor IX recorded at week 0 (immediately before next dose was given). |
| Secondary | Terminal Half-life (t1/2) | Week 0 (30 minutes until one week after first exposure) | Terminal half life is presented at week 0, 30 minutes until one week after first exposure. |
| Secondary | Trough Level (Steady State) | From week 4 to EOT (approximately week 544) | The mean pre-dose factor IX levels was measured with the one-stage clotting assay during the trial. The estimated mean of the lowest activity recorded immediately before next dose was given from week 4 to EOT approximately (week 544). Data is reported for specific age groups in which participants were a part of at any time from week 4 to EOT, not at specific time points assessed from week 4 to EOT. The analysis is based on a mixed model on the log-transformed plasma concentrations with participant as a random effect and the mean trough level is presented back-transformed to the natural scale. Considering the time frame, actual age groups (adolescents and adults) are added for this outcome measure. |
| Secondary | Number of Adverse Events | Week 0 to EOT (approximately week 544) | An adverse event (AE) was any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Here, data is presented for all adverse events (serious adverse events and other adverse events) from week 0 to EOT approximately (week 544). Data is reported for specific Age Groups in which participants were a part of at any time from week 0 to EOT, not at specific time points assessed from week 0 to EOT (approximately week 544). Considering the time frame, actual age groups (adolescents and adults) are added for this outcome measure. |
| Secondary | Number of Serious Adverse Events (SAEs) | Week 0 to EOT (approximately week 544) | A SAE was an experience that at any dose resulted in any of the following: death, a life-threatening experience a), In-patient hospitalisation or prolongation of existing hospitalisation b) a persistent or significant disability/incapacity c) a congenital anomaly/birth defect, Important medical events d) that did not result in death, were life-threatening a) or required hospitalization. Here, data is presented from week 0 to EOT (approximately week 544). Data is reported for specific Age Groups in which participants were a part of at any time from week 0 to EOT, not at specific time points assessed from week 0 to EOT (approximately week 544). Considering the time frame, actual age groups (adolescents and adults) are added for this outcome measure. |
| Secondary | Medical Events of Special Interest (MESI) | Week 0 to EOT (approximately week 544) | The following events were defined as MESIs: -Medication errors concerning trial products, -Administration of wrong drug, * Wrong route of administration, * Administration of a high dose with the intention to cause harm, e.g. suicide attempt, * Administration of an accidental overdose: more than 20 % from the intended dose, * Inhibitor formation against factor IX (FIX), * Thromboembolic events, * Anaphylactic reaction. * Allergic reaction including, but not limited to, any acute immunoglobulin E (IgE) mediated reaction or delayed type hypersensitivity. Here, data is presented from week 0 to EOT (approximately week 544). Data is reported for specific Age Groups in which participants were a part of at any time from week 0 to EOT, not at specific time points assessed from week 0 to EOT (approximately week 544). Considering the time frame, actual age groups (adolescents and adults) are added for this outcome measure. |
| Secondary | Development of Host Cell Protein (HCP) Antibodies | From week 0 to EOT (approximately week 544) | Participants were examined for the development of antibodies against HCP. Number of participants who developed antibodies against HCP is presented. |
| Secondary | FIX Consumption Described as Frequency of Dose/kg for Prophylaxis Use for the Treatment of Bleeding Episodes | From week 0 to EOT (approximately week 544) | Consumption of nonacog beta pegol for treatment of bleeding episodes International units per kilogram per year (IU/Kg/year) per participant is presented from week 0 to EOT approximately (week 544). Data is reported for specific Age Groups in which participants were a part of at any time from week 0 to EOT, not at specific time points assessed from week 0 to EOT (approximately week 544). Considering the time frame, actual age groups (adolescents and adults) are added for this outcome measure. |
| Secondary | FIX Consumption Described as Amount Consumed for the Treatment of Bleeding Episodes | From week 0 to EOT (approximately week 544) | Average dose of nonacog beta pegol for treatment of bleed from start to stop of bleed is presented from week 0 to EOT approximately (week 544) in international units per kilogram per bleed (IU/Kg/bleed). Data is reported for specific Age Groups in which participants were a part of at any time from week 0 to EOT, not at specific time points assessed from week 0 to EOT (approximately week 544). Considering the time frame, actual age groups (adolescents and adults) are added for this outcome measure. |
| Secondary | Number of Doses of FIX Consumed for the Treatment of Bleeding Episodes | From week 0 to EOT (approximately week 544) | Number of doses of FIX consumed for the treatment of bleeding episodes is presented from week 0 to EOT approximately (week 544). Here, data of number of doses of FIX for the treatment of bleeding episodes is reported among all the participants in an arm. Data is reported for specific Age Groups in which participants were a part of at any time from week 0 to EOT, not at specific time points assessed from week 0 to EOT (approximately week 544). Considering the time frame, actual age groups (adolescents and adults) are added for this outcome measure. |
| Secondary | Area Under the Curve Activity Versus Time Profile From Time Zero to 168 Hours Post Dose (AUC(0-168)) | 0-168 hours post-dosing at week 0 | Area under the curve activity versus time profile from time zero to 168 hours post dose of nonacog beta pegol is presented. |
| Secondary | Clearance (CL) | 0-168 hours post-dosing at week 0 | Clearance of nonacog beta pegol after single dose is presented. |
| Secondary | Mean Residence Time (MRT) | 0-168 hours post-dosing at week 0 | Mean residence time (MRT) of nonacog beta pegol after single dose is presented. |
| Secondary | Volume of Distribution at Steady State (Vss) | 0-168 hours post-dosing at week 0 | Volume of distribution at steady state (Vss) of nonacog beta pegol is presented. |
| Secondary | FIX Activity at 30 Minutes (C30min) (Single Dose) | 30 min post-dosing at week 0 | FIX activity (international units per milliliter (IU/mL)) at 30 minutes after single dose is presented. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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